Quality of Life and Sexual Function of the Novasure Endometrial Ablation in Menorrhagia

NCT01910584 | Unknown DMC

• 1 other identifier: First-GYN-SYSU-2012
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the influence on the quality of life and sexual function before, 6 month and one year after Novasure Endometrial Ablation in the treatment of Menorrhagia.

Conditions

Quality of Life; Sexual Activity

Keywords

quality of life; sexual activity; Novasure endometrial ablation; menorrhagia

Outcome Measures

Primary Outcomes (1)

• Quality of life and Sexual Function before, six month and one year after the Novasure Endometrial Ablation

  Quality of life assessed with Health Related Quality of Life questionnaire(HRQoL) before, six month and one year after the Novasure Endometrial Ablation; Sexual Function measured with Female Sexual Functioning Index questionnaire(FSFI) before, six month and one year after the Novasure Endometrial Ablation

  one year after Novasure Endometrial Ablation

Study Arms (1)

Novasure treated group

patients diagnosed menorrhea were treated with novasure endometrial ablation

Procedure: Novasure endometrial ablation

Interventions

Novasure endometrial ablation PROCEDURE

Novasure endometrial ablation is the second generation endometrial ablation treatment aimed to cure the dysfunctional uterine bleeding(DUB),including menorrhagia.

Novasure treated group

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

100 patients diagnosed menorrhagia scheduled for Novasure endometrial ablation in The First Affiliated Hospital between November 2012 and November 2015

You may qualify if:

• clinical diagnosis of menorrhagia
• family complete
• normal endometrial pathology
• had not been referred specifically for surgery
• with normal uterine cavity

You may not qualify if:

• pregnancy or demand to preserve fertility
• acute reproductive tract inflammation or urinary tract inflammation
• pathology demonstrate endometrial cancer or precancerous change
• acute pelvic inflammation
• intrauterine device(IUD) in uterus
• depth of uterine cavity less than 4cm or more than 10cm
• pathologic myometrium( such as history of Hysteromyomectomy or classical cesarean section)

Sponsors & Collaborators

• Shu-Qin Chen: lead

Study Sites (1)

The First Affiliated Hospital of Sun yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Sexual Behavior; Menorrhagia

Condition Hierarchy (Ancestors)

Behavior; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• Shu-Zhong Yao, PhD & MD

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

Central Study Contacts

Shu-Qin Chen, PhD & MD

CONTACT

+862087332200; chenshuqin1021@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor of gynaecology and obstetrics

Study Record Dates

• First Submitted: July 20, 2013
• First Posted: July 29, 2013
• Study Start: November 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 29, 2013

Record last verified: 2012-09

Locations

CN (1)